halozyme therapeutics, inc. · 2 bms i/o portfolio efgarti-gimod efgartigimod ... darzalex...
TRANSCRIPT
Corporate Presentation
Halozyme Therapeutics, Inc.
June 5, 2020
Forward-Looking Statements
In addition to historical information, the statements set forth in this presentation include forward-lookingstatements including, without limitation, statements concerning the Company’s expected future financialperformance (including the Company's financial outlook for 2020) and expectations for profitability, revenue,free cash flow, expenses and earnings-per-share and the Company’s plans to continue its share repurchaseprogram and to potentially expand its platform through acquisitions. Forward-looking statements regarding theCompany’s ENHANZE® drug delivery technology may include the possible activity, benefits and attributes ofENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion andabsorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medicationsthrough subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE® business mayinclude potential growth driven by our partners' development and commercialization efforts (including expectedapproval and product launch of ENHANZE® products), projections for future sales revenue of our collaborators’products, potential new ENHANZE® collaborations, collaborative targets and co-formulation intellectual property,and regulatory review and potential approvals of new ENHANZE® products. These forward-looking statements aretypically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends,""estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words ofsimilar meaning and involve risk and uncertainties that could cause actual results to differ materially from those inthe forward-looking statements. Actual results could differ materially from the expectations contained in theseforward-looking statements as a result of several factors, including unexpected levels of revenues (includingroyalty and milestone revenue received from our collaboration partners), expenditures and costs, unexpecteddelays in the execution of the Company's share repurchase program or platform expansion, unexpected resultsor delays in the growth of the Company’s ENHANZE® business, obtaining new co-formulation intellectual property,or in the development, regulatory review or commercialization of ENHANZE® products, including any potentialdelays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpectedadverse events or patient outcomes and competitive conditions. These and other factors that may result indifferences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K andQuarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
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Commercially Validated ENHANZE® Platform Poised to Drive
Value Creation
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Validated 'IV to Sub Q’ Drug Delivery Platform Partnered
with Premier Pharma and Biotech Companies
ENHANZE® Drug Delivery Technology
Partner Clinical Trial Activity Delivers Near-Term Revenue and
Future Royalty Revenue Growth Following Approval
Highly Profitable Business Model Driven by: • Recurring Royalty Revenue and Substantial Milestone Revenues
• Lean, Scalable Operating Expense Model
• 4 Products approved by FDA, EMA and in multiple global markets
Potential for Competitive Differentiation
Potential for Competitive Differentiation
Potential for Competitive DifferentiationPotential for Competitive Differentiation
Potential for New Intellectual Property for Co-formulations
Reduced Treatment Burden and Healthcare Costs
ENHANZE® Potential Value Drivers for Partners
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ALXN 1810
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2BMS I/O Portfolio
Efgarti-gimod
EfgartigimodFacilitating Higher Injection Volume, Potential to Extend Dosing Interval
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Darzalex FASPROTM Perjeta®/
Herceptin®
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Note: All product names, trademarks and registered trademarks are property of their respective owners
DarzalexFASPROTM
Competitive Differentiation for Daratumumab SC
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Source: ASCO 2019, COLUMBA trial: intravenous versus subcutaneous daratumumab. Presentation by Maria-
Victoria Mateos, MD, PhD, University Hospital of Salamanca-IBSA at 2019 ASCO Annual Meeting
Daratumumab SC: Phase 3 COLUMBA Study
• Primary endpoints met for SC versus IV • PK non-inferiority• Response rate non-inferiority
• 3-5 minute SC administration time
Received FDA Approval
on May 1, 2020
and EMA approval on
June 4, 2020
Potential for Competitive Differentiation with Perjeta®/Herceptin® SC Fixed
Dose Combination (FDC)
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Source: Poster titled Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in
combination with chemotherapy in HER2-positive early breast cancer Tan et al, San Antonio Breast Cancer Symposium,
December 2019
• Primary Endpoint met for SC versus sequential IV Perjeta® (pertuzumab) and Herceptin® (trastuzumab)• PK non-inferiority
Perjeta®/Herceptin® FDC: Phase III (FeDeriCa) Study
1 Roche Pharma Day 2019, London Presentation (September 16, 2019)
• 5-8 minutes SC administration time
Potential for Competitive Differentiation and Extended Dosing Interval with
Efgartigimod
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Source: argenx CIDP KOL event, December 5, 2019
Efgartigimod SC: Phase 1 Trial
Phase 1 Data Support Potential for:
• Fixed-dose versus weight based
• Extended dosing interval
• Self-administration at home
How We Work with Our ENHANZE® Partners
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• Oversee Production and Release of API to partner
• Advise on co-formulation
Halozyme Role Partner Role
• Manufacture co-formulated product for clinical and commercial use
• Advise on PK, PD, regulatory path and clinical trial design
• Design and execute clinical trials
• Attend FDA meetings • Complete rHuPH20-related
aspects of regulatory submissions
• Lead FDA meetings • Complete and submit
regulatory submissions
• No active role in drug promotion
• Fund and execute the launches
Operating Model:• Lean
• Scalable
• Leverageable
Increasing Value of Agreements Driven by Regulatory
and Commercial Success
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2006 2007 2012 2014 2015 2017 2018 2019
One-time Upfront
$20M $10M $8M $15M $23M $25M $105M $30M $40M $25M $30M
Milestones/Target1
$37–
$47M$37M $85M $113M ~$130M ~$160M $160M $160M $160M
$160 -
165M$160M
Targets 8 1 6 5 9 5 11 1 4 3 3
Recurring Average Mid-single Digit Royalties on Net Sales
1Assumes all developmental and commercial milestones per target achieved and paid to Halozyme.
Baxalta Janssen abbvie BMS argenx
ENHANZE® Revenues Streams
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On average, mid-single digit royalty on net sales across all agreements
ENHANZE® Revenues Streams
Upfront: Payment to access technology and specific target(s): $30-40M for 1 or 2
nominated targets in recent deals
Development: Increasing payments as development plan progresses to
approval/first sale: 40-60% of $160M total potential milestones per target
in recent deals
Commercial: Payments as sales thresholds are achieved: 40-60% of $160M total
potential milestones per target in recent deals
Halozyme receives 20% mark-up on bulk sales of API to partners
Royalties
Milestones
API
Confidential and Proprietary
Majority of ENHANZE-partnered Products are Approved, Commercially
Successful Products in their Own Right
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Nivolumab DARZLEX FASPROTM
Our First Three Products Successfully Commercialized in Global Markets
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US ROW
DARZALEX FASPROTM: Latest FDA-approved Drug Using ENHANZE®
• DARZALEX FASPROTM (daratumumab and hyaluronidase – fihj injection) Approved by FDA May 1st
• 5 of 7 indications for which IV form of DARZALEX is currently approved
• Per label1:
• in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
• in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
• Administration time of 3-5 minutes1
• Lower rate of Infusion Related Reactions reported in COLUMBA study2
• 12.7% for SC versus 34.5% for IV
1 DARZALEX FASPROTM Prescribing Information2 ASCO 2019, COLUMBA trial: intravenous versus subcutaneous daratumumab. Presentation by Maria-Victoria Mateos, MD, PhD, University Hospital of Salamanca-IBSA at 2019 ASCO Annual Meeting
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Subcutaneous DARZALEX® Globally
• Granted European Marketing Authorization on June 4, 2020 • Applies to all indications previously approved for DARZALEX IV® in frontline and relapsed/refractory settings,
including:
• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
• as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy
• Japan NDA submission in April 2020
• Commercial Opportunity:• DARZALEX® (daratumumab) in its IV form generated global sales of $3.0B in 2019, representing 48% year-over-
year growth
• Analyst consensus sales1 : $3.9B in 2020, $7.8B in 2024
1 Evaluate Ltd worldwide sales estimates as of February 2020
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Perjeta®/Herceptin® Fixed Dose Combination:
Next Anticipated Product to be Approved Using ENHANZE®
• Perjeta® (pertuzumab) and Herceptin® (trastuzumab) IV use today
• Indicated for combined use: Neoadjuvant, adjuvant and metastatic HER2+Breast Cancer
• Commercial Opportunity:
• Perjeta® IV alone generated sales of $3.6B in 2019(1)
• Analyst consensus sales2 : $4.1B in 2020, $5.4B in 2024
• Following BLA submission in US in December 2019 and MAA submission in Q1 2020, regulatory review underway
• U.S. FDA action date of October 18, 2020
• Perjeta®/Herceptin® Fixed Dose Combination with ENHANZE® Results
• Administration time of 5-8 minutes3
• Positive phase 3 results from FeDeriCa study in patients with HER2-positive early breast cancer
1 Roche FY 2019 Results presentation January 30, 20202 Evaluate Ltd worldwide sales estimates as of February 20203 “Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study”, Tan et al
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ENHANZE® Development Pipeline Projected to Progress and Grow
1 Based on plans communicated by partners
Project 3 Phase 3 trial starts and one Phase 2 trial start in 2020 (1)
Project 5 new Phase 1 starts in 2020(1)
Q1 2020 Phase 1 ongoing or complete Studies
Expect 4 completed and 9ongoing Phase 1 studies by end
2020
• Efgartigimod (argenx)
• Nivolumab (BMS)
• Anti-CD73 (BMS)
• Relatlimab (BMS)
• Atezolizumab (Roche)
• Ocrelizumab (Roche)
• Undisclosed (Lilly)
• Undisclosed
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Projected Milestones Drive Revenue and Free Cash Flow
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2019 2020 2021 2022
2018
Projection
2019
Updated
Projection
2019
Actuals
Milestone Revenue Projection
$225 - $300M
$350 - $450M
$60M
Royalty Revenue Projection: Potential for ~$1B in 2027
Projection based on approved products and assumes global approval and launches for 14 additional products in multiple indications. Includes projections forsubcutaneous versions of targets not currently approved or commercially available. Innovator revenues based on Bloomberg and EvaluatePharma analyst-basedestimates, when available. Conversion rates based on Halozyme internal projections. Royalty revenue projection includes targets selected but not yet disclosed.Projected royalty revenue is not risk–adjusted.
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~$1 Billion
20272020
Capital Allocation Strategy
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Strong commitment to return capital to shareholders
Priorities::
Drive ENHANZE
growthFree Cash Flow
Share
Repurchases
Potential Platform
Expansion via
M&A
• Maximize value of
current collaborations
• Sign new collaborations
• Board-authorized share repurchase program for $550 million
over next three years• $251.6 million worth of share repurchases have been
completed to date• Initial $200M repurchase completed in February
2020 • Additional $51.6M repurchase completed in Q1
2020; 3.2 million shares (1) at a weighted average price of $16.15 per share
• $298.4 million remaining under $550 million Board authorization
• Shares outstanding as of March 31, 2020: 135.4M(1) This is in addition to 0.5 million shares delivered in February upon completion of the ASR
2020 Financial Guidance Unchanged
2020 Guidance*
2020 Drivers
Net Revenue $230M – $245M
• Growth 17% to 25% driven by higher revenues from milestones
• Royalties revenues projected to decline modestly
• 2020 guidance excludes revenue resulting from signing potential
new ENHANZE deal
Diluted GAAP EPS
$0.60 – $0.75
• Continue to expect $65 million to $75 million in annualized
operating expenses by the fourth quarter of 2020 (excl. COGS),
towards high end of the range.
• Does not include potential impact from share repurchases in
2020
* Consistent with guidance first provided on January 14, 2020
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Value-driving Events Anticipated in 2020
❑ U.S. Approval and Launch of DARZALEX FASPROTM
❑ EU approval and launch of DARZALEX® SC
❑ Profitability beginning in Q2
❑ Potential US approval of subcutaneous Perjeta®/Herceptin® FDC and US launch
❑ 3 new Phase 3 trial starts
❑ 5 new targets entering Phase 1
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Corporate Presentation
Halozyme Therapeutics, Inc.
June 5, 2020